510(k) K251355
- Device
- X1-FFR
- Applicant
- Spectrawave, Inc.
- 510(k) number
- K251355
- Product code
- QHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-17
- Date received
- 2025-04-30
- Regulation
- 892.1600
- Classification name
- X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ankit Shah
- Address
- 12 Oak Park Dr. Bedford MA US 01730 01730
FDA Registration Numbers#
- 3038136528
- 9614587
- 9710122
- 3017654247
Source Documents#
Other 510(k) Records For Product Code QHA#
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|---|---|---|---|
| K243769 | QFR (3.0) | Qfr Solutions BV | 2025-04-04 |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024-04-09 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023-02-28 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019-05-30 |